Safety needle cannula module that is activated by a safety syringe and plunger module

ABSTRACT

A safety needle cannula module in interchangeable combination with a safety syringe and plunger module, wherein the safety needle cannula module is formed with one of a variety of needle cannula sizes and wherein said safety syringe may be one of a variety of syringe sizes. The safety needle cannula module with needle cannula of desired size is attached to a safety syringe module wherein said safety syringe is a desired size. After medication is injected into a body with the safety needle cannula and the safety syringe, the safety syringe module reacts with the safety needle cannula module and further causes said safety needle cannula to be automatically retracted and disposed within the hollow plunger within said safety syringe module.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a single-use syringe for injecting medicineinto a patient. More particularly, the invention relates to a safetysyringe having a retractable needle cannula that renders the needlecannula harmless after it is used.

2. Background of the Related Art

Many communicable diseases can be spread through the penetration orscratching of the skin by a needle that was previously used by anotherhaving the disease. Spreading of the disease in this manner may occur byaccident, such as with medical personnel making injections, or it mayoccur through misuse, such as by intravenous drug users using apreviously used needle cannula.

Various syringes have been invented, designed and developed to retractthe needle into the syringe or the plunger inside of the syringe. Someof these devices are U.S. Pat. No. 4,973,316 (Dysarz), U.S. Pat. No.4,978,343 (Dysarz), U.S. Pat. No. 5,180,369 (Dysarz), U.S. Pat. No.5,267,961 (Shaw), U.S. Pat. No. 5,019,044 (Tsao), U.S. Pat. No.5,084,018 (Tsao), U.S. Pat. No. 5,385,551 (Shaw), U.S. Pat. No.5,389,076 (Shaw), and U.S. Pat. No. 5,201,710 (Caselli). These designshave needles which retract at the end of the injection. Most of thesedesigns have not reached the market due, at least in part, to problemsassociated with the expense of manufacturing, poor reliability or useracceptability. However, even though some of these designs operate poorlyor are costly, they have still been commercialized due to the great needin hospitals or clinics for any type of safety syringe.

Most of the existing safety syringe designs allow for automaticretraction of the needle cannula into the plunger barrel of the syringewhen the plunger is fully extended into the syringe. The automaticretraction is triggered when the plunger makes physical contact with thedistal end of the syringe barrel. Typically, the end of the plunger isprovided with a disengagable or sacrificial member at the distar end andthe needle cannula is secured by a disengageable or sacrificial member.When the plunger reaches the fully extended position, the physicalcontact between the plunger and the needle cannula causes activation ofthe two respective disengageable or sacrificial members. In this manner,the end of the plunger barrel is opened and presented to receive theneedle cannula. The needle cannula, no longer secured in position, isbiased into the plunger barrel by a spring.

Conventional syringes are typically available in modular systems or kitsin which approximately ten different sizes of syringes and approximatelyten different sizes of needle cannulas can be used interchangeably. Thisallows an inventory of twenty items to be used in approximately 100different combinations in accordance with the present need. However, thesafety syringes presently available and described in the above patentsare not modular and require stocking of an integral safety syringes foreach combination of syringe size and needle cannula size desired, forexample 100 different safety syringes. Particularly, in light of thegreater cost of these syringes, the cost, distribution and storage ofsafety syringes is much greater than conventional syringes.

Despite the prevalence of modular conventional syringes, the emergenceof a multitude of safety syringe designs and the increasing publicoutcry for safety syringes, the complexities of the safety syringemechanisms have limited the number of attempts to design a safetysyringe that is modular. Two such attempts include modular syringe tipdesigns that are combined with a conventional syringe as described inU.S. Pat. No. 5,891,093 (Dysarz) and U.S. Pat. No. 5,935,113 (Dysarz).Compared with the foregoing automatically retracting safety syringes,these two designs can be considered to have safety needle cannulaassemblies that are self-contained and manually operated, while beingconnectable to a conventional syringe with a conventional lockingarrangement. While these devices serve the aforementioned need formodularity, the obvious drawbacks to the devices include the manualretraction mechanism and the additional length that the needle cannulaassembly adds to the syringe.

Therefore, there remains a need for a modular safety syringe system orkit that provides a selection of syringe modules having various sizesand 2 selection of needle cannula modules having various sizes that canbe combined on site to form an automatically retractable safety syringeof a desired configuration. It would be desirable if the automaticallyretractable safety syringe had similar length and usability as aconventional syringe. It would be further desirable if the usedautomatically retractable safety syringe was compact and secure againstaccidental needle sticks.

SUMMARY OF THE INVENTION

The invention provides a kit of components for assembling modular safetysyringes. The kit comprises two or more safety syringe modules havingdifferent diameters and two or more safety needle cannula modules. Eachsafety syringe module has a syringe barrel; a safety plunger extendingthrough a proximal end of the syringe barrel, wherein the safety plungerhaving a plunger barrel, a sliding gasket formed along the perimeter ofthe plunger barrel near the distal end for sealing the plunger againstthe interior sidewalls of the syringe barrel, a sealing member coveringan opening in the distal end of the plunger barrel, and a rigid memberadjacent the sealing member; and a connector formed in the distal end ofthe syringe barrel. Each of the two or more safety needle cannulamodules have a housing having a connector formed at a proximal end ofthe housing and a cannula passage formed through a distal end of thehousing; a needle cannula extending through the cannula passage; aslidable piston flange coupled to the needle cannula; a retaining membersecuring the slidable piston flange in the proximal end of the housing;and a spring disposed within the housing to bias the slidable pistonflange in the direction of the plunger opening from the distal endtowards the proximal end. The connectors in the two or more safetysyringe modules are sealably securable to the connectors in the two ormore safety needle cannula modules. Accordingly, securing any one of thetwo or more safety needle cannula modules to any one of the two or moresafety syringe modules provides alignment of the rigid member of theplunger with the retaining member of the safety needle cannula moduleand alignment of the slideable piston flange with the sealing member ofthe plunger.

Preferably, the rigid member of the plunger is an end ridge, possiblysloped. The retaining element is selected from a shear plate, breakplate, a friction ring, a sacrificial membrane, or a snapon ring. Wherethe retaining element is a shear plate or a break plate, it mayoptionally include first and second concentric notches formed therein,preferably such that the rigid member is aligned to contact theretaining element between the first and second concentric notches.Similarly, the sealing member is selected from a break plate, a frictionplug, a sacrificial membrane, a snapon plug. The connectors are selectedfrom threads, luer-loks, or snap-on fittings.

Another aspect of the invention provides an improvement to a medicaldevice having an elongate hollow body; a movable hollow member slidableaxially in the body; a retraction mechanism including a needle extendingfrom the body for injecting or collecting fluid, a needle holding memberhaving an unretracted position, a spring for applying retraction forceto the needle holding member in a retraction direction, and a retainingelement capable of holding the needle holding member against theretraction force provided by the spring; and a cap releasably sealing apassage in the end of the movable hollow member that is positionedwithin the body; the retaining element being triggered to retaining theneedle holding member for retraction of the needle in response toselective movement of the movable member, and the cap being retainingdfrom the passage of the movable hollow member in response to theselective movement of the movable member. The improvement comprises asloping end ridge formed on the end of the movable hollow member tocontact the retaining element upon selective movement of the movablemember. For example, the retaining element may be selected from a breakplate, a friction ring, a sacrificial membrane, or an interference fitand may be triggered by failing, sliding, or disengaging. Particularly,the retaining element or cap may be sloped along with the sloping endridge.

Yet another aspect of the invention provides an improvement to a medicaldevice having an elongate hollow body; a movable hollow member slidableaxially in the body; a retraction mechanism including a needle extendingfrom the body for injecting or collecting fluid, a needle holding memberhaving an unretracted position, a spring for applying retraction forceto the needle holding member in a retraction direction, and a retainingelement capable of holding the needle holding member against theretraction force provided by the spring; and a cap releasably sealing apassage in the end of the movable hollow member that is positionedwithin the body; the retaining element being triggered to release theneedle holding member for retraction of the needle in response toselective movement of the movable member, and the cap being releasedfrom the passage of the movable hollow member in response to theselective movement of the movable member. The improvement comprises aspring shield coupled to the needle holding member and extending aroundthe spring, wherein the spring is disposed concentrically around theneedle. Preferably, the spring shield is a tube disposed concentricallyaround the spring, where the spring shield has an outer diameter that isless that an internal diameter of the passage in the movable hollowmember.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the above recited features and advantages of the presentinvention can be understood in detail, a more particular description ofthe invention, briefly summarized above, may be had by reference to theembodiments thereof which are illustrated in the appended drawings. Itis to be noted, however, that the appended drawings illustrate onlytypical embodiments of this invention and are therefore not to beconsidered limiting of its scope, for the invention may admit to otherequally effective embodiments.

FIG. 1 is an elevation view of the safety needle cannula module and thesafety syringe and plunger module.

FIG. 2 is an elevation view of the safety needle cannula module fixed tothe safety syringe and plunger module.

FIG. 3 is a section elevation of the safety needle cannula module shownfixed to the safety syringe module.

FIG. 3A is a section elevation of two safety syringes having differentsyringe barrel diameters.

FIG. 3B is an enlarged section elevation of the needle cannula module.

FIG. 3C is an enlarged section elevation of the first end of the plungermodule.

FIG. 3D is an enlarged section elevation of the threaded connectionbetween the safety needle cannula module and the syringe module.

FIG. 4 is a section view of the safety needle cannula module and thesafety syringe module as taken through FIG. 3.

FIG. 5 is a section view of the safety syringe module and a plan view ofthe safety plunger module within the safety syringe module.

FIG. 6 is a section elevation of the safety plunger module moving towardthe safety needle cannula module.

FIG. 7 is a section elevation of the first end of the safety plungermodule touching the safety needle cannula module.

FIG. 8 is a section elevation of the safety needle cannula module pointloading the first end of the plunger module.

FIG. 9 is a section elevation of the slideable piston and needle cannulathrusting into the plunger module.

FIG. 10 is a section elevation of the safety needle cannula and theslideable piston inside of the safety plunger module.

FIG. 11 is a section elevation of the safety needle of the secondpreferred embodiment.

FIG. 12 is a section elevation of the first end of the plunger modulewith a slope.

FIG. 13 is a section elevation of the sloping first end of the plungermodule point loading the slideable piston barrier.

FIG. 14 is a section elevation of the needle and base plate thrustinginto the plunger module.

FIG. 15 is a section elevation of the needle, the spring shield and thebase plate inside of the plunger.

FIG. 16 is a plan view of the notches on the shear plate andconcentrated load plate.

FIG. 17 is a plan view of the notches on the shear plate andconcentrated load plate.

FIG. 18 is a plan view of the notches on the shear plate andconcentrated load plate.

FIG. 19 is a plan view of the notches on the shear plate andconcentrated load plate.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides a modular safety syringe system or kitthat provides a selection of safety syringe modules having various sizesand a selection of needle cannula modules having various sizes that canbe combined on site to form an automatically retractable safety syringeof a desired configuration. In addition to requiring a common interfacebetween the safety syringe module and needle cannula module, as withconventional modular systems, the present invention also requires andfacilitates a specific cooperative relationship between the syringeplunger module and the needle cannula module.

Each safety syringe module of the present invention includes a syringebarrel, a safety plunger extending through a proximal end of the syringebarrel, and a connector formed in the distal end of the syringe barrel.A syringe barrel may be of any length and diameter, as dictated by thevolume of fluid to be delivered through the syringe, and will include aconnector have a fixed diameter. In systems, sets or kits having aplurality of syringes with different diameters, each syringe should havea connector with a common diameter and a common connection type. Forexample, three syringe barrels may be provided with diameters of 2, 2.5and 3 centimeters, respectively, but each of the three syringe barrelsshould have a connector of the same type, such as threads, and of thesame diameter, such as 1.5 centimeters. It should be recognized that insets having syringes with wide variations in syringe barrel diameter,the set may include a first subset of syringes having a first commonconnector with a first common diameter and a second subset of syringeshaving a second common connector with a second common diameter. Thepresent invention contemplates any number of subsets, each subset havingthe same or different type of connector, and each subset having the sameor different connector diameter. It should be recognized that the term"diameter" as used herein shall not be limited to the dimensions of acircular opening, but shall include the dimensions of any shape ofopening, for example shapes like squares, triangles, ovals, andrectangles.

The safety plungers of the present invention have suitable lengths anddiameters to work in a cooperative relationship inside the syringebarrels. It is anticipated that each syringe of a different diameterwill have a corresponding safety plunger of suitable size. The safetyplunger has a plunger barrel, a sliding gasket formed along theperimeter of the plunger barrel near the distal end for sealing theplunger against the interior sidewalls of the syringe barrel, and aremovable member sealing a central opening in the distal end of theplunger barrel. The safety plunger will also include a lip or similarstructure that engages a critical portion of the needle cannula moduleas described below.

The safety needle module has a connector that is designed to be coupledto the connector on the safety syringe module. These connectors may beof various types, including but not limited to male/female threads,snap-on, and luer-lok tips. In systems, sets or kits having a pluralityof safety needle modules with different cannula diameters, gauges, typesor lengths, each safety needle module should have a connector with acommon diameter and a common connection type. For example, three safetyneedle modules may be provided with, but not limited to, 16G, 20G and30G cannulas, respectively, but each of the three modules should have aconnector of the same type, such as male threads, and of the samediameter, such as 1.5 centimeters. Furthermore, it should be recognizedthat the safety needle modules will preferably all have the same type ofconnector, such as male threads or the male portion of a luer-lok, andthe safety syringe modules will preferably all have the same type ofconnector that mates with the needle module connector, such as femalethreads of the female portion of a luer-lok. In the case where there aresubsets of syringes having connectors with different diameters, thenthere will also be subsets of safety needle modules having connectorswith the same mating diameters.

The safety needle module includes a housing having the connector at theproximal end and a cannula passage through the distal end. A needlecannula coupled to a slidable piston flange extends through the cannulapassage. The slidable piston flange is secured to the housing by adisengageable, sacrificial or retaining member. A spring is disposedwithin the housing to bias the slidable piston flange, and consequentlythe needle cannula, away from the distal end towards the proximal end.The spring surrounds the needle cannula and is maintained in a biased orspring loaded condition between the distal end of the housing and theslidable piston flange. It is important that the spring providesufficient force to move the needle cannula into the plunger barrel uponrelease, but the spring should not be so strong as to fatigue or causefailure to the disengageable or sacrificial member that secures theslidable piston flange to the housing.

It should be recognized that the disengageable or sacrificial members inthe safety plunger and in the safety needle module may take many forms,including plates that can fail, break or shatter as described in U.S.Pat. No. 5,180,369 (Dysarz) incorporated by reference herein,frictionally engaged retaining rings and plugs as described in U.S. Pat.No. 5,285,551 incorporated by reference herein, sacrificial membranes,interference fits, and the like.

It is a critical aspect of the invention that a rigid component of thesafety plunger is disposed at an appropriate position to engage andactuate the retaining member in the safety needle module and that arigid component of the safety needle module is disposed at anappropriate position to engage and actuate the sealing member in thesafety plunger. Since syringes typically have cylindrical barrels,although they could just as well have any shaped cross-section, thepositions of the two rigid components, the sealing member and theretaining member can be described in terms of concentric members havinga specific radial distance from the axial centerline of the needlecannula. While two of the concentric members are in the safety plungerand the other two concentric members are in the needle module, themembers must achieve a standard, fixed or consistent cooperativerelationship when assembled and, consequently, must have standard radiior other dimension and threads specified for each of the two rigidcomponents, the sealing member and the retaining member. For any givenset or subset of safety syringe modules and safety needle modules, theseradii must be the same regardless of the syringe diameter or the cannulagauge. In other words, the size and alignment of the members accountingfor the automatic retraction must be consistent in order for theretraction to occur.

Consistent alignment of the members, including alignment of a rigidplunger member with the needle retaining member and alignment of therigid safety needle member with the plunger sealing member, can beachieved either by (a) using a constant plunger barrel diameterregardless of syringe diameter, or (b) using plunger barrels having adiameter just smaller than the syringe barrel, but having a diameter atthe distal end that is reduced, or perhaps even increased, to form orachieve the fixed radii of the rigid plunger component. The formeroption is less desirable, because the plunger barrel could wobble fromside to side and the gasket member would not receive as much physicalsupport.

Now referring to the Figures, FIG. 1 is an elevation view of the systemor kit of the present invention. The system includes a separate safetysyringe module and a safety needle cannula module. The safety syringemodule includes a safety plunger 1 and a syringe module 2. A syringeconnector 6 is shown formed in the distal end of the syringe barrel 2,preferably forming a set of female threads. Finger tabs 4 are shown atthe proximal end of the syringe barrel 2. The syringe barrel 2 is ahollow elongated barrel with an inside surface and an outside surface.The safety plunger 1 is also an elongated barrel with an inside surfaceand an outside surface. The safety plunger is shown disposed within thesyringe barrel 2 with a thumb flat 5 shown at the proximal end of thesafety plunger.

The safety needle cannula module 3 is shown with a needle cannula 8extending from the distal end of a housing 46 having male threads thatare attachable to the female threads formed on the syringe connector 6of the syringe barrel 2. A needle protector cap 7 is shown removeablyfixed to the distal end of the safety needle cannula module 3 to preventany contamination to the needle cannula 8 and to further protect theneedle cannula point 10. Gripping members or wings I 1 are also shownformed on the exterior of the safety needle cannula module 3 to allowfor ease of gripping the safety needle cannula module 3 while threadingthe safety needle cannula module 3 to the syringe connector 6 of thesafety syringe module.

FIG. 2 is an elevation view of the safety needle cannula module 3suitably attached to the safety syringe module 12 via a threadedconnection. The needle protector 7 that was protecting the needlecannula 8 in FIG. 1 has been removed and the assembled device consistingof the two modules 3, 12 is ready to be used.

FIG. 3 is a section elevation of the device, as taken through FIG. 2.The safety plunger 1 is shown formed into a frustoconical surface orother tapered surface 15 at the distal end and a sliding gasket 13 isshown having syringe sealing surfaces. The plunger sealing member 14 isshown in this embodiment as a push in barrier borne on the distal end ofthe cone 15, where the cone 15 has a diameter matching up with aretaining member 23, shown in this embodiment as a point load plate. Thesealing member 14 has sufficient strength to withstand typical hydraulicpressures that can be exerted on it while the plunger is thrustingmedicament into a body, however, the sealing member will fail ordisengage and be pushed into the plunger cavity 17 whenever the forceapplied on the thumb flat is provided as a concentrated load applied tothe sealing member. In the embodiment where the sealing member is a pushin barrier, it is preferable that a point load or an eccentric load isapplied to the barrier.

The term "concentrated load", as used herein, means a load or force thatis directed at a specific member or portion of a member, as opposed to aload of similar magnitude that is spread out over a large surface area.For example, when a syringe has been filled with medicine, the advancingplunger applies a load to the fluid in the syringe that pushes againstall surfaces exposed to the fluid. By contrast, when all the medicinehas been dispensed, the rigid member of the advancing plunger makescontact with a portion of the retaining member such that the entireamount of force applied to the thumb flat is directed against thatportion of the retaining member. It is this latter load that is referedto as a "concentrated load."

The housing 46 has a threaded connector 9 formed on the proximal end ofthe needle cannula module 3 and the connector 9 is shown suitably meshedand fixed to the female threads 18 formed on the syringe connector 6,shown in this embodiment as an extended collar. The connection formedbetween the threads of the two modules should be a fluid (gas andliquid) tight connection. A needle passage 19 is shown formed in thedistal end of the safety needle cannula module 3 that allows the needlecannula 8 to retract into the inside of the safety plunger 1 withoutoscillating transversably.

The needle cannula 8 is shown suitably fixed to a slideable piston 20 byadhesive or friction or some other means by design choice. The distalend of the slideable piston 20 is near the cannula flat 21. A slideablepiston flange 22 is formed near the proximal end of the slideable piston20. A retaining member 23, shown in this embodiment as a point loadplate, secures the proximal end of the slideable piston 20 to thehousing 46. A biased spring 24 is compressed between the cannula flat 21and the slideable piston flange 22 in order to bias the slideable pistonflange, and consequently the needle cannula, toward the plunger barrel.

The point load plate 23 is shown formed on the slideable piston flange22 and extends near the inside surface of the housing 46 of the safetyneedle cannula module 3. The point load plate 23 is suitably fixed tothe inside surface of the safety needle cannula module by adhesive,plastic, welding, friction, snap-on or some other suitable means bydesign choice.

FIG. 3A is a section elevation of two safety syringe modules 12, 12' asmight be provided as part of a kit of components for on site assemblingof automatically retractable safety syringes. The two safety syringemodules 12, 12' have syringe barrels 2, 2' with different diameters fordrawing and injecting different quantities of fluid. Despite thedifferent syringe barrel diameters, each safety syringe module 12,12' iscoupled through the same type (here, common pitch and style threads) andsame size (here, diameter ×and length) of connectors to a safety needlecannula module 3. The diameters of the safety plungers 1, 1' and thegaskets 13, 13 are dictated by the different diameters of the syringebarrels 2, 2'. However, according to the present invention, even thoughthe plunger diameter changes with the syringe diameter, the safetyplunger 1 must maintain a rigid component or end ridge 30 at a fixedradial distance y from the axial centerline of the syringe to be inalignment with the retaining member 23 of the safety needle cannulamodule 3. Similarly, the slideable piston flange of the needle cannulamodule 3 must be maintained in alignment with the sealing member of theplunger 1.

FIG. 3B is an enlarged section elevation as taken from FIG. 3 showingmore clearly the safety needle cannula module 3. The safety needlecannula module 3 has a connector 39 suitably fixed or assembled to thesyringe connector 6 formed on the distal end of the syringe barrel 2,shown here as male threads 39 on the connector 9 mating with femalethreads 18 formed on the syringe barrel 2. The biased spring 24 is showncompressed between the slideable piston flange 22 and the cannula flat21. The needle cannula 8 is shown suitably secured to the slideablepiston 20. The proximal end of the needle cannula 8 is shown with acannula flange 25. The slideable piston flange 22 is formed on theproximal end of the slideable piston 20, allowing the biased spring 24to thrust against the slideable piston flange 22.

In one preferred embodiment, the slideable piston flange 22 is held,secured or fixed to a point load plate 23. The point load plate 23 ispreferably provided with a first break away notch 31 and a secondbreakaway notch 34 formed in the proximal side of the point load plate23. The breakaway notches could be formed on the distal side of thepoint load plate 23 or the proximal side of the point load plate 23 bydesign choice. The point load plate 23 is designed to fail when a pointload is applied or when a concentrated load is applied to the necessarylocation. It should be recognized that the failure mode of the pointload plate may include breaking, shattering, tearing or otherwisereleasing the slideable piston flange. Most preferably, the point loadplate 23 is suitably fixed to the inside surface of the safety needlecannula module 3 with a snap on fluid and gas tight connection, althoughit should be recognized that adhesives or other means could be utilizedto secure applied by design choice.

FIG. 3C is an enlarged section elevation of the push in barrier 14secured to the end ridge 30 at the first end of the rigid plunger memberor cone 15. While the barrier is shown attached at the distal-mostsurface of the end ridge, it should be recognized that the barrier maybe attached to an inner surface of the end ridge 30, the cone 15 oranother surface of the plunger. Further, while it is preferred that theend ridge 30 or a portion of the barrier 14 extend distally from the endof the sliding gasket, it is anticipated that the gasket could be madecompressible so that the "end ridge" is normally recessed but, uponcompression of the gasket, presents itself to contact the retainingmember.

The sliding gasket 13 is shown attached to the plunger, preferably alongthe outer surface of the cone 15. The push in barrier 14 is shown with abreak off notch 32 that is circumferential in this particular figure,however, break off notches could be included in any number, pattern ordimension. Specifically, the break off notch 32 could bisect the push inbarrier 14 in various directions by design choice. The push in barrier14 should be strong enough to withstand any hydraulic pressure appliedto its distal (medicament exposed) side, but should be unable towithstand any point loading, concentrated load or eccentric loaddirected on the barrier without breaking away from the end ridge 30.Where any unequally applied load is generated on the push in barrier 14,the push in barrier will break off at or near the break of notch 32.Again, it should be recognized that the failure mode of the push inbarrier may include breaking, shattering, tearing or otherwise renderingaccess to the plunger cavity 17.

FIG. 3D is an enlarged section elevation of the snap on connection astaken through FIG. 3B. The point load plate 23 is shown with a snap onchannel 27 formed at the outer circumference of the plate. A snap on rib28 is shown formed on the inside circumference essentially near theproximal end of the safety needle cannula module 3. A backing ridge 29is shown as another means of securing the point load plate 23 inposition. Part of the syringe connector 6 and syringe barrel 2 are shownfor reference.

FIG. 4 is a section plan view as taken through FIG. 3. The syringebarrel wall 2 is shown at the outer periphery and the outside diameterof the syringe connector 6 is shown as a hidden (dashed) line. Theinside diameter of the syringe extension 6 is shown as a solid line forreference purposes. The first break away notch 31 and the second breakaway notch 34 are part of the point load plate 23 and are shown aroundthe cannula flange 25. The cannula 33 is shown at near the cannulaflange 25.

FIG. 5 is another section elevation as taken through FIG. 3. Here, thebreak off notch 32 is shown on the inside and the outer periphery of thepush in barrier is shown around the break off notch 32. The slidinggasket 13 is shown rubbing on the inside surface of the syringe barrel2.

FIG. 6 is another enlarged section elevation of the safety plunger 1 inthe proximity of, and being moved toward, the safety needle cannulamodule 3. As shown, the safety plunger 1 is moving in a closingdirection 35 toward the distal end of the syringe barrel. The rigidcomponent or end ridge 30 is moving toward the point load plate 23between the connector 9 and the slideable piston flange 22. The push inbarrier 14 is also moving into the slideable piston flange 22 and thecannula flange 25. The exposed side of the cannula flange 25 could beflush with the piston flange 22 by design choice. A centerline 38 isshown for reference purposes.

FIG. 7 is a section elevation of the distal side of the push in barrier14 thrusting into the proximal side of the cannula flange 25 whilecontinuing to move in a closing direction 35. If the cannula flange 25were flush with the slideable piston flange 22, the distal side of thepush in barrier 14 would first come into contact with the proximal sideof the slideable piston flange. In either case, the result issubstantially the same.

FIG. 8 is a section elevation view of the break away ring 36 beingdisengaged from the point load plate 23. The breakaway ring 36 isdefined by the first break away notch 31 and the second breakaway notch34 formed in the point load plate 23. As the end ridge 30 is thrust intothe point load plate 23, the plate is supported on the outside peripheryby the snap on rib 28 and the backing ridge 29 thereby not allowing anydeflection along the outside periphery of the point load plate 23. Thepoint load plate 23 is also supported near the center of the point loadplate by the slideable piston flange 22. The slideable piston flange 22is supported by the slideable piston 20 which, in turn, has a distal endsupported by the cannula flat 21 to prevent any deflection between theslideable piston flange 22 and the point load plate 23. Because of thissupport and the load applied by the end ridge, the point load platefails at the first break away notch 31 and the second break away notch34, thereby forming the break away ring 36 which is thrust into thesafety needle cannula module chamber 37. As the break away ring 36 isthrust into the safety needle cannula module chamber 37, the slideablepiston flange 22 and the slideable piston 20 are thrusting into the pushin barrier with a point load or a concentrated load thus causing breakoff notch 32 formed in the push in barrier 14 to fail and allowing thepush in barrier to be thrust in an inward direction 68 into the insideof the safety plunger 1.

FIG. 9 is a section elevation view of the slideable piston flange 23,and the slideable piston 20 being thrust in an inward or proximaldirection 68 into the inside of the safety plunger module 1 by thebiased spring 24 having a distal end that is thrusting on the cannulaflat 21 and a proximal end thrusting on the slideable piston flange 22.

FIG. 10 is a section elevation view of the needle cannula and slideablepiston 20 having been retracted inside of the safety plunger 1. Thebiased spring 24 is now an relaxed, elongated spring 24. Optionally, thespring may be either loose or suitably fixed at the distal end to thecannula flat 21. The push in barrier 14 is shown as being separated fromthe end of the plunger and being inside the safety plunger 1, but it isanticipated that the barrier may remain partially attached to the endridge.

FIG. 11 is a section elevation of the safety syringe 40 of a secondpreferred embodiment. There are two variations or differences betweenthe safety syringe 40 of the second preferred embodiment and the safetysyringe 12 of the first preferred embodiment. These variations include asloping end ridge 41, a spring shield 42, and the elimination of theslideable piston.

The spring shield 42 is seen protecting the coiled biased spring 47 fromcatching anything that might impede the spring's ability to thrust theneedle cannula shaft 44 all the way into the elongated hollow plunger45. The spring shield 42 is contained in the safety cannula housing 46with the distal end of the needle cannula shaft 44 extending out fromthe distal end of the safety cannula housing 46. A coiled, biased spring47 is coiled about the needle cannula shaft 44. The proximal end of thecoiled biased spring 47 pushes against the base plate 48 and the distalend of the coiled biased spring 47 pushes against the cannula flat 49.The syringe barrel 50 is shown as an elongated hollow barrel with anoutside surface and an inside surface. The outside surface of theelongated hollow plunger 45 has an outer surface that is only slightlysmaller than the inside surface of the syringe 50.

FIG. 12 is an enlarged section elevation of the safety cannula housing46. The needle cannula shaft 44 has a distal end terminating in a point,a proximal end and a cannula 52 formed on the inside of the needlecannula shaft 44. The needle cannula shaft 44 is shown with the distalend extending past the distal end of the safety cannula container 46,through the needle passage 53, through the coiled biased spring 47wherein the proximal end of the needle cannula shaft 44 is suitablyfixed to the base plate 48. The needle cannula shaft 44 may be fixed tothe base plate 48 by adhesive, welding, friction or any other suitablemeans by design choice. The coiled biased spring 47 has a distal endbiased against the needle flat 49 and a proximal end biased against thedistal side of the base plate 48. The coiled biased spring 47 iscontained by the needle cannula shaft 44 on the inside circumference ofthe coiled biased spring 47 and by the inside surface of the springshield 42. The spring shield 42 is shown with the first end near ortouching the needle flat 49. The proximal end of the spring shield 42 isshown fixed to the distal side of the base plate 48. The spring shield42 is shown with the distal end near or touching the needle flat 49 toprevent any deflection or bending of the spring 47 or the needle cannulashaft 44. The needle flange 54 is shown suitably fixed to the proximalside of the base plate 48. The retaining member or shear plate 55 isshown with a first notch 56 and a second notch 57 wherein the shearplate 55 will withstand the maximum amount of hydraulic or pneumaticpressure that the syringe is designed to produce. However, when a pointload or a concentrated load is applied to the shear plate 55 at aparticular point, the shear plate 55 will fail at the first notch 56 andthe second notch 57 or at another location on the shear plate 55.

The shear plate 55 is suitably secured to the base plate 48 on theinside with adhesive or some other suitable means, preferably forming afluid tight barrier therebetween. The outside perimeter of the shearplate 55 is shown suitably fixed to the inside of the safety cannulahousing 46 by adhesive or other suitable means, preferably forming afluid tight barrier.

The safety cannula housing 46 is shown suitably fixed to the syringeconnector 58 that is formed at the distal end of the syringe 50,preferably including threads 59 but optionally including any typeconnector.

The sloping end ridge 41 is shown near the shear plate 55. As theelongated hollow plunger 45 is pushed toward the needle cannula shaft 44in a shear plate direction 60, the concentrated load plate 61 is shownwith a slope 62 relative to the centerline 38. This slope 62 allows thesloping end ridge 41 to impact the shear plate 55 at only one pointthereby exerting a point load on a small area, thereby initiatingfailure of the shear plate 55 and starting a progressive tearing processon the shear plate 55. The concentrated load plate 61 is thrust into acorner on the proximal side of the base plate 48 thereby exerting aconcentrated load on the concentrated load plate 61, which load is inexcess of the load that any hydraulic fluid would have applied duringthe operation of the safety syringe. In this manner, the concentratedload plate 61 will shear in one area and progressively tear away theentire outer periphery of the concentrated load plate 61 as the plunger45 is thrust further toward the shear plate 55.

Where the concentrated load plate or other sealing member 61 is sloped,an optional spacer 70 may be used, preferably attached to the face ofthe member 61, to reduce or eliminate space in the syringe that willtrap fluid therein. The spacer 70 is preferably made from a soft andeasily compressible material to allow the

FIG. 13 is an enlarged section elevation of the sloping end ridge 41thrusting into the shear plate 55 in a shear plate direction 60. Thebreak off ring 63 is now broken away from the shear plate 55. The cornerof the base plate 48 is being pushed against by the concentrated loadplate 61, causing the concentrated load plate 61 to progressively fail,tear or shear off of the sloping end ridge 41. The concentrated loadplate 61 is shown moving in an inward direction 68. Because the endridge does not protrude from the end of the plunger past the plungergasket, the plunger gasket is shown as being somewhat compressed beforethe

FIG. 14 is an enlarged section elevation of the needle cannula shaft 44surrounded by the coiled biased spring 47 (in the process of unbiasing)and the spring shield 42 thrusting past the remainder of the shear plate61 as the needle is thrusted into the elongated hollow plunger 45 in aninward direction 68.

FIG. 15 is a section elevation of the safety syringe 40 with the needlecannula shaft 44 safely in the elongated hollow plunger 45. The coiledspring 15 now unbiased is holding the needle cannula shaft 44 and thebase plate 48 in the elongated hollow plunger 45. The needle cannulashaft 44 is now unable to come back out of the needle tunnel 53 toinjure others or to be reused. There are other means of holding theelongated hollow plunger 45 inside of the syringe 50.

FIGS. 16, 17, 18 and 19 show various notch configurations suitable foruse on either the shear plate 55 or the concentrated load plate 61. FIG.16 has the notches forming concentric circles 64. FIG. 17 has radialnotches 65. FIG. 18 has spiral notch(es) 66. FIG. 19 has star notches67. There could be an infinite number of notch configurations by designchoice.

Although the syringes and syringe systems described in detail above havebeen found to be most satisfactory and preferred, many variations arepossible. For example the point load plate may not have notches in thefirst or second side, the point load plate may be square or rectangular,the concentrated load plate may be of various thicknesses or the safetyneedle cannula module may be axially offset.

Although the invention has been described with reference to thepreferred embodiments, it will be understood by those skilled in theart, that additions, modifications, subtractions, deletions and otherchanges not specifically described, may be made in the embodimentherein. It should be understood that the details herein are to beinterpreted as illustrations and are not in a limiting sense.

What is claimed is:
 1. A kit of components for assembling safetysyringes, comprising:(a) two or more safety syringe modules havingdifferent diameters, each safety syringe module having:(1) a syringebarrel; (2) a safety plunger extending through a proximal end of thesyringe barrel, the safety plunger having a plunger barrel, a slidinggasket formed along the perimeter of the plunger barrel near the distalend for sealing the plunger against the interior sidewalls of thesyringe barrel, a sealing member covering an opening in the distal endof the plunger barrel, and a rigid member adjacent the sealing member;and (3) a connector formed in the distal end of the syringe barrel; (b)two or more safety needle cannula modules having:(1) a housing having aconnector formed at a proximal end of the housing and a cannula passageformed through a distal end of the housing; (2) a needle cannulaextending through the cannula passage; (3) a slidable piston flangecoupled to the needle cannula; (4) a retaining member securing theslidable piston flange in the proximal end of the housing; and (5) aspring disposed within the housing to bias the slidable piston flange inthe direction of the plunger opening from the distal end towards theproximal end; (c) wherein the connectors in the two or more safetysyringe modules are sealably securable to the connectors in the two ormore safety needle cannula modules; and (d) wherein securing any one ofthe two or more safety needle cannula modules to any one of the two ormore safety syringe modules provides alignment of the rigid member ofthe plunger with the retaining member of the safety needle cannulamodule and alignment of the slideable piston flange with the sealingmember of the plunger.
 2. The kit of claim 1, wherein the rigid memberof the plunger is an end ridge.
 3. The kit of claim 2, wherein the endridge is sloped.
 4. The kit of claim 1, wherein the retaining element isselected from a shear plate, break plate, a friction ring, a sacrificialmembrane, or a snapon ring.
 5. The kit of claim 1, wherein the sealingmember is selected from a break plate, a friction plug, a sacrificialmembrane, a snapon plug.
 6. The kit of claim 1, wherein the connectorsare selected from threads, luer-loks, or snap-on fittings.
 7. The kit ofclaim 1, wherein the needle cannulas of the two or more safety needlecannula modules are different sizes.
 8. The kit of claim 1, wherein theplunger barrel narrows near the distal end to form the rigid member. 9.The kit of claim 8, wherein the plunger barrel narrows along afrustoconical surface.
 10. The kit of claim 1, wherein the retainingelement is selected from a shear plate or break plate and has first andsecond concentric notches formed therein, and wherein the rigid memberis aligned to contact the retaining element between the first and secondconcentric notches.